Apparatus and methods for positioning and securing anchors

ABSTRACT

Apparatus and methods for positioning and securing anchors are disclosed herein. The anchors are adapted to be delivered and implanted into or upon tissue, particularly tissue within the gastrointestinal system of a patient. The anchor is adapted to slide uni-directionally over suture such that a tissue plication may be cinched between anchors. A locking mechanism, either within the anchor itself or positioned proximally of the anchor, may allow for the uni-directional translation of the anchor while enabling the anchor to be locked onto the suture if the anchor is pulled, pushed, or otherwise urged in the opposite direction along the suture. This uni-directional anchor locking mechanism facilitates cinching of the tissue plication between the anchors, and it may be utilized in one or several anchors in cinching a tissue fold.

PRIORITY CLAIMS

This application is a Continuation of U.S. patent application Ser. No.13/569,019, filed Aug. 7, 2012, and now pending, which is a Continuationof U.S. patent application Ser. No. 11/036,866, filed Jan. 14, 2005, andnow U.S. Pat. No. 8,257,394, which is a Continuation-In-Part of U.S.patent application Ser. No. 10/840,950, filed May 7, 2004, now U.S. Pat.No. 8,308,765. All of these applications are incorporated herein byreference in their entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to apparatus and methods for positioningand securing anchors within tissue. More particularly, the presentinvention relates to apparatus and methods for positioning and securinganchors within folds of tissue within a body.

Morbid obesity is a serious medical condition pervasive in the UnitedStates and other countries. Its complications include hypertension,diabetes, coronary artery disease, stroke, congestive heart failure,multiple orthopedic problems and pulmonary insufficiency with markedlydecreased life expectancy.

A number of surgical techniques have been developed to treat morbidobesity, e.g., bypassing an absorptive surface of the small intestine,or reducing the stomach size. However, many conventional surgicalprocedures may present numerous life-threatening post-operativecomplications, and may cause atypical diarrhea, electrolytic imbalance,unpredictable weight loss and reflux of nutritious chyme proximal to thesite of the anastomosis.

Furthermore, the sutures or staples that are often used in thesesurgical procedures typically require extensive training by theclinician to achieve competent use, and may concentrate significantforce over a small surface area of the tissue, thereby potentiallycausing the suture or staple to tear through the tissue. Many of thesurgical procedures require regions of tissue within the body to beapproximated towards one another and reliably secured. Thegastrointestinal lumen includes four tissue layers, wherein the mucosalayer is the inner-most tissue layer followed by connective tissue, themuscularis layer and the serosa layer.

One problem with conventional gastrointestinal reduction systems is thatthe anchors (or staples) should engage at least the muscularis tissuelayer in order to provide a proper foundation. In other words, themucosa and connective tissue layers typically are not strong enough tosustain the tensile loads imposed by normal movement of the stomach wallduring ingestion and processing of food. In particular, these layerstend to stretch elastically rather than firmly hold the anchors (orstaples) in position, and accordingly, the more rigid muscularis and/orserosa layer should ideally be engaged. This problem of capturing themuscularis or serosa layers becomes particularly acute where it isdesired to place an anchor or other apparatus transesophageally ratherthan intraoperatively, since care must be taken in piercing the toughstomach wall not to inadvertently puncture adjacent tissue or organs.

One conventional method for securing anchors within a body lumen to thetissue is to utilize sewing devices to suture the stomach wall intofolds. This procedure typically involves advancing a sewing instrumentthrough the working channel of an endoscope and into the stomach andagainst the stomach wall tissue. The contacted tissue is then typicallydrawn into the sewing instrument where one or more sutures or tags areimplanted to hold the suctioned tissue in a folded condition known as aplication. Another method involves manually creating sutures forsecuring the plication.

One of the problems associated with these types of procedures is thetime and number of intubations needed to perform the various proceduresendoscopically. Another problem is the time required to complete aplication from the surrounding tissue with the body lumen. In the periodof time that a patient is anesthetized, procedures such as for thetreatment of morbid obesity or for GERD must be performed to completion.Accordingly, the placement and securement of the tissue plication shouldideally be relatively quick and performed with a minimal level ofconfidence.

Another problem with conventional methods involves ensuring that thestaple, knotted suture, or clip is secured tightly against the tissueand that the newly created plication will not relax under any slackwhich may be created by slipping staples, knots, or clips. Otherconventional tissue securement devices such as suture anchors, twistties, crimps, etc. are also often used to prevent sutures from slippingthrough tissue. However, many of these types of devices are typicallylarge and unsuitable for low-profile delivery through the body, e.g.,transesophageally.

Moreover, when grasping or clamping onto or upon the layers of tissuewith conventional anchors, sutures, staples, clips, etc., may of thesedevices are configured to be placed only after the tissue has beenplicated and not during the actual plication procedure.

BRIEF SUMMARY OF THE INVENTION

In securing plications which may be created within a body lumen of apatient, various methods and devices may be implemented. Generally, anynumber of conventional methods may be utilized for initially creatingthe plication. One method in particular may involve creating a plicationthrough which a tissue anchor may be disposed within or through. Adistal tip of a tissue plication apparatus may engage or grasp thetissue and move the engaged tissue to a proximal position relative tothe tip of the device, thereby providing a substantially uniformplication of predetermined size. Examples of tools and methods which areparticularly suited for delivering the anchoring and securement devicesmay be seen in further detail in co-pending U.S. patent application Ser.No. 10/735,030 filed Dec. 12, 2003, which is incorporated herein byreference in its entirety.

In securing these plications, various tissue anchors may be utilized forsecuring the plications in their configured folds. For example, aplication (or plications) may be secured via a length or lengths ofsuture extending through the plication and between a distally-positionedtissue anchor located on a distal side of the plication and aproximally-positioned tissue anchor located on a proximal side of theplication. Examples of anchors which may be utilized are disclosed inco-pending U.S. patent application Ser. No. 10/612,170, filed Jul. 1,2003, which is incorporated herein by reference in its entirety.

Generally, in securing a tissue plication, a proximally and/or distallylocated tissue anchor is preferably configured to slide along theconnecting suture in a uni-directional manner. For instance, if theproximal anchor is to be slid along the suture, it is preferablyconfigured to translate over the suture such that the tissue plicationis cinched between the anchors. In this example, the proximal anchor ispreferably configured to utilize a locking mechanism, which allows forthe free uni-directional translation of the suture therethrough whileenabling the anchor to be locked onto the suture if the anchor ispulled, pushed, or otherwise urged in the opposite direction along thesuture. This uni-directional anchor locking mechanism facilitates thecinching of the tissue plication between the anchors and it may beutilized in one or several of the anchors in cinching a tissue fold.

Moreover, the types of anchors utilized for the securement of tissueplications are not intended to be limiting. For instance, many of theanchor locking or cinching mechanisms may be utilized with, e.g.,“T”-type anchors as well as with reconfigurable “basket”-type anchors,which generally comprise a number of configurable struts or legsextending between at least two collars or support members. Othervariations of these or other types of anchors are also contemplated foruse in an anchor locking or cinching assembly.

Furthermore, a single type of anchor may be used exclusively in ananchor locking or cinching assembly; alternatively, a combination ofdifferent anchor types each utilizing different anchor locking orcinching mechanisms may be used in a single assembly. Furthermore, thedifferent types of cinching or locking mechanisms are not intended to belimited to any of the particular variations shown and described belowbut may be utilized in any combinations or varying types of anchors aspracticable.

The suture itself may be modified or altered to integrate features orprotrusions along its length or a specified portion of its length. Suchfeatures may be defined uniformly at regular intervals along the lengthof suture or intermittently, depending upon the desired locking orcinching effects. Furthermore, the suture may be made from metals suchas Nitinol, stainless steels, Titanium, etc., provided that they areformed suitably thin and flexible. Using metallic sutures with theanchoring mechanisms may decrease any possibilities of suture failureand it may also provide a suture better able to withstand the acidic andbasic environment of the gastrointestinal system. Also, it may enhanceimaging of the suture and anchor assembly if examined under imagingsystems. Sutures incorporating the use of features or protrusions alongits length as well as sutures fabricated from metallic materials or anyother conventional suture type may be utilized with any of the lockingor cinching mechanisms described below in various combinations, if sodesired.

One variation for utilizing a locking mechanism which allows for freeuni-directional translation of the suture through the anchor may includeblocks or members which are adapted to slide within or upon an anchor tolock the suture. These blocks or members may include tapered edges whichact to cleat the suture depending upon the direction the anchor istranslated relative to the suture. Moreover, these blocks may be biasedor urged to restrict the movement of the suture using a variety ofbiasing elements, such as springs, etc. In addition to blocks, one orseveral locking tabs which are levered to allow uni-directional travelof the suture through an anchor may also be utilized.

Aside from the use of mechanical locking features integrated within orwith the anchor bodies, locking mechanisms may also utilize a variety ofknotting techniques. Conventional knots, which are typically tied by thepractitioner either within the body or outside the body and advancedover the suture length, may be utilized for locking the anchor in placerelative to the tissue fold and opposing anchor; however, self-lockingknots which enable the uni-directional travel of an anchor body relativeto the suture and tissue are desirable. Accordingly, many differenttypes of self-locking knots may be advanced with the anchor over thesuture such that translation along a distal direction is possible yetreverse translation of the anchor is inhibited.

Various anchor cinching or locking mechanisms utilizing friction as aprimary source for locking may also be implemented. For instance,locking pins may be urged or pushed into a frictional interference fitwith portions or areas of the suture against the anchor or portions ofthe anchor. The use of such pins may effectively wedge the suture andthereby prevent further movement of the anchor along the suture length.In addition to pins, locking collars or collets may also be used tocinch or lock the suture.

In addition to friction-based locking and cinching mechanisms utilizablein tissue anchors, other mechanisms which create tortuous paths for thesuture within or through the anchors may also be utilized for creatinguni-directional locking. One cinching variation may utilize a pulley orpin contained within the anchor over which a portion of the suture maytravel. The looped suture may then be routed proximally and secured witha slip knot. As tension is applied to the suture, the slip knot mayprevent the further movement of the anchor relative to the suture.

Another variation on utilizing tortuous paths may comprise collars whichare independent from or integrally formed with the anchors. Suchcinching collars may generally be formed into tubular structures havingobstructions or interference elements formed within the collar lumen.The obstructions may, for example, be formed from portions of thecinching collar itself that are adapted to form upon releasing of aconstraining force when the anchor is to be locked into position.Alternatively, the interference elements or obstructions may compriseseparate elements disposed within the collar lumen, such as one or moreballs, etc. These obstructions or elements may be used to form atortuous path through which the suture may be routed to lock the suture.

Moreover, locking collars which form tortuous paths may be adapted toreconfigure themselves from a constrained delivery configuration to adeployed locking configuration when the anchor is to be cinched orlocked into position relative to the tissue and suture. The lockingcollars may be configured to take various configurations, such as aproximally extending “S”-type, or other types, configuration.

Other cinching and locking mechanisms which utilize mechanical clampingor crimping to achieve locking of the suture within or through theanchors may also be used to facilitate uni-directional locking. Forinstance, a simple mechanical crimp may be fastened upon the sutureproximally of the anchor to prevent the reverse motion of the anchor.The crimp may be a simple tubular member or it may be integrally formedonto a proximal portion of the anchor body itself.

Aside from the crimping mechanisms described above, additional measuresmay be optionally implemented to facilitate the cinching or locking ofan anchor. Other measures may also be taken to inhibit any damage fromoccurring to the suture routed through an anchor. For instance, toensure that the integrity of the suture is maintained in the presence ofmetallic basket anchors and to ensure that the suture is not subjectedto any nicks or cuts, the portion of the suture passing through basketanchor may be encased in a protective sleeve made, e.g., frompolypropylene, PTFE, etc.

Another measure which may optionally be implemented are cinching orlocking mechanisms which take advantage of any cold-flow effects of anengaged portion of suture by the tissue anchor. For instance, if aportion of the suture is wedged against the collar of an anchor orcinching member to lock the anchor, the portion of the collar may havemultiple holes defined over its surface to allow for portions of theengaged suture to cold-flow at least partially into or through the holesto enhance the locking effects.

Alternatively, the collar may be formed with an electrically conductiveinner sleeve surrounded by an outer sleeve capable of flowing at leastpartially when heated. The inner sleeve may have a number of holesdefined over its surface such that when the outer sleeve is heated,either by inductive heating or any other method, the outer sleevematerial may flow through the holes and into contact with the suturepassing therethrough. This contact may also enhance the locking effectsof the collar.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of one variation of a tissue plicationapparatus which may be used to create tissue plications and to delivercinching or locking anchors into the tissue.

FIGS. 1B and 1C show detail side and perspective views, respectively, ofthe tissue manipulation assembly of the device of FIG. 1A.

FIGS. 2A to 2D show an example of a tissue plication procedure for thedelivery and placement of tissue anchors.

FIGS. 3A to 3G show detail cross-sectional views of an anchor deliveryassembly in proximity to a tissue plication and an example of deliveringthe tissue anchors on distal and proximal sides of the plication.

FIGS. 4A and 4B show side and end views, respectively, of one anchorvariation which is illustrated in the form of a T-type anchor utilizinglocking blocks or members for cinching and locking the suture.

FIG. 5 shows a side view of another cinching anchor variation utilizinglocking blocks or members.

FIG. 6 shows yet another side view of a cinching anchor variationutilizing locking blocks or members.

FIG. 7 shows a perspective view of another locking anchor variation inwhich the anchor body defines an opening having a tapered or groovedportion.

FIGS. 8A and 8B show cross-sectional side and top views, respectively,of another locking anchor variation utilizing a through-hole passage oropening and uni-directional levers or pivots through which the suturemay pass.

FIG. 8C shows a cross-sectional side view of an anchor body incombination with a modified suture having integrated features orprotrusions defined along its length.

FIGS. 9A and 9B show cross-sectional views of locking anchor variationshaving biased locking members in combination with a knotted suture.

FIG. 9C shows another modification of the suture which may be coatedwith a metallic covering or slid within a sleeve.

FIG. 10 shows a cross-sectional side view of an anchor assembly whichutilizes a choke-type loop for cinching the anchors uni-directionallytowards one another.

FIG. 11A shows a perspective view of another anchor assembly utilizing aslip knot at the proximal anchor.

FIGS. 11B and 11C show top and cross-sectional side views, respectively,of an anchor which may optionally define grooves or channels extendingat least partially therein to facilitate the cinching or wedging of thesutures within the grooves.

FIGS. 12A to 12G show examples of anchor assemblies utilizing variousslip knots and looped sections which provide uni-directional travel forthe anchors over the sutures.

FIG. 13A shows a cross-sectional side view of an anchor delivery systemdelivering a basket-type anchor into or through a tissue plication.

FIG. 13B shows a cross-sectional side view of multiple tissue plicationswhich may be cinched towards one another and basket anchors as beingdeliverable through one or both tissue plications.

FIGS. 14A and 14B show cross-sectional side views of an anchor cinchingassembly utilizing a cinching collar or collet which may be wedged intoan anchor collar for clamping upon the suture.

FIGS. 15A and 15C show cross-sectional side views of another anchorcinching assembly utilizing a pin for wedging against a portion of thesuture.

FIGS. 15B and 15D show end views of the assembly of FIGS. 15A and 15C,respectively.

FIG. 15E shows a perspective view of another cinching variationutilizing one or more tapered pins or blocks slidably disposed within atapered channel defined in a proximal collar of the anchor.

FIG. 15F shows a perspective view of the tapered pins from FIG. 15E.

FIGS. 15G and 15H show cross-sectional side views of an alternativecinching assembly having a retractable pin in an engaged and disengagedconfiguration, respectively.

FIGS. 16A and 16B show cross-sectional side views of another variationof a cinching assembly having a rotatable cinching collar.

FIGS. 17A and 17B show cross-sectional side views of another cinchingassembly having a retaining tube for providing a counterforce tostabilize the assembly during cinching or locking.

FIGS. 18A and 18B show cross-sectional side views of another cinchingassembly having one or several biasing members or cinching tabs.

FIGS. 18C and 18D show end and perspective views, respectively, of asuture release member which may be used with the assembly of FIGS. 18Aand 18B.

FIGS. 19A and 19B show cross-sectional side views of another variationof a cinching assembly utilizing a deformable cinching member positionedwithin the anchor and distally of the anchor collar.

FIG. 20A shows a cross-sectional side view of another cinching assemblyutilizing a pivoting cinching member configured to lock against thesuture.

FIGS. 20B, 20C, and 20D show end and cross-sectional side views,respectively, of the pivoting member positioned within the anchorcollar.

FIGS. 20E and 20F show cross-sectional side and perspective views,respectively, of another cinching assembly having a pivoting cinchingmember positioned proximally of the anchor collar.

FIGS. 21A and 21B show cross-sectional side views of another cinchingassembly configured to cinch or lock the suture with a tapered collar.

FIG. 22A shows a cross-sectional side view of another cinching assemblyutilizing a looped suture and a slip knot for cinching the anchor overthe suture.

FIGS. 22B and 22C show cross-sectional side and detail views,respectively, of another cinching assembly which may be utilized with aportion of suture wrapped or looped about a pin which enablesuni-directional travel of the anchor relative to the suture

FIGS. 22D and 22E show cross-sectional side and detail views,respectively, of another cinching assembly utilizing looped suturewedged within the anchor collar.

FIG. 23 shows a cross-sectional side view of a cinching assemblyvariation utilizing a number of pulleys to create the cinching effect.

FIG. 24A shows a cross-sectional side view of another cinching assemblyvariation in which a cinching sleeve may be used to create a tortuouspath for the suture.

FIGS. 24B and 24C show cross-sectional side views of another cinchingassembly variation having a tubular structure, with and withoutretaining arms, respectively, positioned within the anchor collarthrough which the suture may pass uni-directionally.

FIG. 24D shows a perspective view of one variation of the tubularstructure of FIG. 24C with retaining arms.

FIGS. 25A and 25B show cross-sectional side views of another cinchingassembly variation in which a cinching collar, which may be independentof the anchor or formed integrally with the anchor, respectively, mayhave a tortuous path formed within the collar.

FIG. 25C shows a perspective view of the collar of FIG. 25A in itsunobstructed configuration with a constraining sleeve which may bepositioned within the collar.

FIGS. 26A and 26B show cross-sectional side views of another cinchingassembly variation utilizing one or several pivoting levers which allowunidirectional travel of the suture therethrough.

FIGS. 26C and 26D show alternative end views of the assembly of FIG. 26Ain which the lever may be configured to prevent over cinching onto thesuture.

FIGS. 26E to 26G show cross-sectional side views of alternative cinchingassemblies in which the levers may be variously configured to create thetortuous path.

FIGS. 27A and 27B show side views of another cinching assembly variationin a delivery profile and a reconfigured profile, respectively, whichutilizes a crimp which may be self-forming.

FIGS. 28A and 28B show cross-sectional side views of another cinchingassembly variation utilizing either two cinching collars or a singleintegral cinching collar, respectively.

FIG. 28C shows a cross-sectional side view of the cinching collar ofFIG. 28A in one configuration for cinching the suture.

FIGS. 28D and 28E show perspective views of the cinching collar of FIG.28A in a delivery profile and a reconfigured profile.

FIG. 28F shows a cross-sectional side view of another variation for acinching configuration of the cinching collar of FIG. 28B.

FIGS. 28G and 28H show cross-sectional side views of another cinchingassembly variation in a delivery profile and reconfigured profile,respectively, in which an elongate cinching member may reconfigureitself to create a tortuous path for the suture.

FIGS. 29A and 29B show cross-sectional side views of another cinchingassembly variation utilizing a mechanical crimp.

FIGS. 30A and 30B show cross-sectional side views of another cinchingassembly variation in which a mechanical crimp may be utilized on theproximal collar of the anchor body.

FIG. 31A shows a cross-sectional side view of a variation of a toolassembly which may be adapted to apply a mechanical crimping force upona crimping collar.

FIGS. 31B to 31D show side, end, and perspective views, respectively, ofa variation on a crimping collar which may be utilized as a separatecrimping sleeve or as part of the anchor collar.

FIGS. 32A and 32B show cross-sectional side and perspective views,respectively, of an alternative crimping tool.

FIGS. 33A and 33B show perspective and end views, respectively, of arepresentative basket anchor having a protective sleeve encasing thesuture disposed within the anchor.

FIGS. 34A and 34B show cross-sectional side and perspective views,respectively, of a cinching collar defining a plurality of holes throughthe surface of the collar for enhancing the locking effects with thesuture.

FIG. 35A shows a cross-sectional side view of a cinching assemblyvariation which may utilize inductive heating to partially melt aportion of an outer sleeve into contact with the suture to enhance theanchor locking effects.

FIGS. 35B and 35C show perspective assembly and exploded views,respectively, of an electrically conductive inner sleeve containedwithin the outer sleeve.

FIGS. 35D and 35E show perspective views of alternative inner sleeveswhich may be utilized with the assembly of FIG. 35A.

FIGS. 36A and 36B are side-views, partially in section, of a cinchingassembly comprising an interference element.

FIGS. 37A-37C are, respectively, an isometric view, a sectionalisometric view and a side-sectional view of the cinching assembly ofFIG. 36.

FIGS. 38A-38D are side-views, partially in section, of variations of thecinching assembly of FIGS. 36 and 37.

DETAILED DESCRIPTION OF THE INVENTION

In order to first create the plication within a body lumen of a patient,various methods and devices may be implemented. The anchoring andsecurement devices may be delivered and positioned via an endoscopicapparatus that engages a tissue wall of the gastrointestinal lumen,creates one or more tissue folds, and disposes one or more of theanchors through the tissue fold(s). The tissue anchor(s) may be disposedthrough the muscularis and/or serosa layers of the gastrointestinallumen.

Generally, in creating a plication through which a tissue anchor may bedisposed within or through, a distal tip of a tissue plication apparatusmay engage or grasp the tissue and move the engaged tissue to a proximalposition relative to the tip of the device, thereby providing asubstantially uniform plication of predetermined size.

Formation of a tissue fold may be accomplished using at least two tissuecontact areas that are separated by a linear or curvilinear distance,wherein the separation distance between the tissue contact pointsaffects the length and/or depth of the fold. In operation, a tissuegrabbing assembly engages or grasps the tissue wall in its normal state(i.e., non-folded and substantially flat), thus providing a first tissuecontact area. The first tissue contact area then is moved to a positionproximal of a second tissue contact area to form the tissue fold. Thetissue anchor assembly then may be extended across the tissue fold atthe second tissue contact area. Optionally, a third tissue contact pointmay be established such that, upon formation of the tissue fold, thesecond and third tissue contact areas are disposed on opposing sides ofthe tissue fold, thereby providing backside stabilization duringextension of the anchor assembly across the tissue fold from the secondtissue contact area.

The first tissue contact area may be utilized to engage and then stretchor rotate the tissue wall over the second tissue contact area to formthe tissue fold. The tissue fold may then be articulated to a positionwhere a portion of the tissue fold overlies the second tissue contactarea at an orientation that is substantially normal to the tissue fold.A tissue anchor may then be delivered across the tissue fold at or nearthe second tissue contact area. An apparatus in particular which isparticularly suited to deliver the anchoring and securement devicesdescribed herein may be seen in further detail in co-pending U.S. patentapplication Ser. No. 10/735,030 filed Dec. 12, 2003 and entitled“Apparatus And Methods For Forming And Securing Gastrointestinal TissueFolds”, which is incorporated herein by reference in its entirety.

An illustrative side view of a tissue plication assembly 10 which may beutilized with the tissue anchors described herein is shown in FIG. 1A.The plication assembly 10 generally comprises a catheter or tubular body12 which may be configured to be sufficiently flexible for advancementinto a body lumen, e.g., transorally, percutaneously, laparoscopically,etc. Tubular body 12 may be configured to be torqueable through variousmethods, e.g., utilizing a braided tubular construction, such that whenhandle 16 is manipulated and rotated by a practitioner from outside thebody, the torquing force is transmitted along body 12 such that thedistal end of body 12 is rotated in a corresponding manner.

Tissue manipulation assembly 14 is located at the distal end of tubularbody 12 and is generally used to contact and form the tissue plication,as mentioned above. FIG. 1B shows an illustrative detail side view oftissue manipulation assembly 14 which shows launch tube 18 extendingfrom the distal end of body 12 and in-between the arms of upperextension member or bail 20. Launch tube 18 may define launch tubeopening 24 and may be pivotally connected near or at its distal end viahinge or pivot 22 to the distal end of upper bail 20. Lower extensionmember or bail 26 may similarly extend from the distal end of body 12 ina longitudinal direction substantially parallel to upper bail 20. Upperbail 20 and lower bail 26 need not be completely parallel so long as anopen space between upper bail 20 and lower bail 26 is sufficiently largeenough to accommodate the drawing of several layers of tissue betweenthe two members.

Upper bail 20 is shown in the figure as an open looped member and lowerbail 26 is shown as a solid member; however, this is intended to bemerely illustrative and either or both members may be configured aslooped or solid members. Tissue acquisition member 28 may be an elongatemember, e.g., a wire, hypotube, etc., which terminates at a tissuegrasper 30, in this example a helically-shaped member, configured to bereversibly rotatable for advancement into the tissue for the purpose ofgrasping or acquiring a region of tissue to be formed into a plication.Tissue acquisition member 28 may extend distally from handle 16 throughbody 12 and distally between upper bail 20 and lower bail 26.Acquisition member 28 may also be translatable and rotatable within body12 such that tissue grasper 30 is able to translate longitudinallybetween upper bail 20 and lower bail 26. To support the longitudinal androtational movement of acquisition member 28, an optional guide or sled32 may be connected to upper 20 or lower bail 26 to freely slidethereon. Guide 32 may also be slidably connected to acquisition member28 such that the longitudinal motion of acquisition member 28 issupported by guide 32.

An example of a tissue plication procedure is seen in FIGS. 2A to 2D fordelivering and placing a tissue anchor and is disclosed in furtherdetail in co-pending U.S. patent application Ser. No. 10/735,030 filedDec. 12, 2003, which has been incorporated by reference above. Tissuemanipulation assembly 14, as seen in FIG. 2A, may be advanced into abody lumen such as the stomach and positioned adjacent to a region oftissue wall 40 to be plicated. During advancement, launch tube 18 may beconfigured in a delivery profile such that tube 18 is disposed within orbetween the arms of upper bail 20 to present a relatively small profile.

Once tissue manipulation assembly 14 has been desirably positionedrelative to tissue wall 40, tissue acquisition member 30 may be advanceddistally such that tissue acquisition member 30 comes into contact withtissue wall 40 at acquisition location or point 42. As acquisitionmember 30 is distally advanced relative to body 12, guide 32, ifutilized, may slide distally along with member 30 to aid in stabilizingthe grasper. If a helically-shaped acquisition member 30 is utilized, asillustrated in FIG. 2B, it may be rotated from its proximal end athandle 16 and advanced distally until the tissue at point 42 has beenfirmly engaged by acquisition member 30. This may require advancement ofacquisition member 30 through the mucosal layer and at least into orthrough the underlying muscularis layer and preferably into or throughthe serosa layer.

The grasped tissue may then be pulled proximally between upper 20 andlower bails 26 via acquisition member 30 such that the acquired tissueis drawn into a tissue fold 44, as seen in FIG. 2C. As acquisitionmember 30 is withdrawn proximally relative to body 12, guide 32 may alsoslide proximally to aid in stabilizing the device especially whendrawing the tissue fold 44.

Once the tissue fold 44 has been formed, launch tube 18 may be advancedfrom its proximal end at handle 16 such that a portion 46 of launch tube18, which extends distally from body 12, is forced to rotate at hinge orpivot 22 and reconfigure itself such portion 46 forms a curved orarcuate shape that positions launch tube opening 24 perpendicularlyrelative to a longitudinal axis of body 12 and/or bail members 20, 26.Launch tube 18, or at least portion 46 of launch tube 18, is preferablyfabricated from a highly flexible material or it may be fabricated,e.g., from Nitinol tubing material which is adapted to flex, e.g., viacircumferential slots, to permit bending. Alternatively, assembly 14 maybe configured such that launch tube 18 is reconfigured simultaneouslywith the proximal withdrawal of acquisition member 30 and acquiredtissue 44.

As discussed above, the tissue wall of a body lumen, such as thestomach, typically comprises an inner mucosal layer, connective tissue,the muscularis layer and the serosa layer. To obtain a durable purchase,e.g., in performing a stomach reduction procedure, the staples oranchors used to achieve reduction of the body lumen are preferablyengaged at least through or at the muscularis tissue layer, and morepreferably, the serosa layer. Advantageously, stretching of tissue fold44 between bail members 20, 26 permits an anchor to be ejected throughboth the muscularis and serosa layers, thus enabling durablegastrointestinal tissue approximation.

As shown in FIG. 2D, once launch tube opening 24 has been desirablypositioned relative to the tissue fold 44, needle assembly 48 may beadvanced through launch tube 18 via manipulation from its proximal endat handle 16 to pierce preferably through a dual serosa layer throughtissue fold 44. Needle assembly 48 is preferably a hollow tubular needlethrough which one or several tissue anchors may be delivered through andejected from in securing the tissue fold 44, as further described below.

Because needle assembly 48 penetrates the tissue wall twice, it exitswithin the body lumen, thus reducing the potential for injury tosurrounding organs. A detail cross-sectional view is shown in FIG. 3A ofanchor delivery assembly 50 in proximity to tissue fold F. In thisexample, tissue fold F may comprise a plication of tissue created usingthe apparatus 10 described herein or any other tool configured to createsuch a tissue plication. Tissue fold F may be disposed within agastrointestinal lumen, such as the stomach, where tissue wall W maydefine the outer or serosal layer of the stomach. Anchor deliveryassembly may generally comprise launch tube 18 and needle assembly 48slidingly disposed within launch tube lumen 52. Needle assembly 48 isgenerally comprised of needle 54, which is preferably a hollow needlehaving a tapered or sharpened distal end 66 to facilitate its travelinto and/or through the tissue. Other parts of the assembly, such asupper and lower bail members 20, 26, respectively, and tissueacquisition member 28 have been omitted from these figures only forclarity.

Once launch tube 18 has been desirably positioned with respect to tissuefold F, needle 54 may be urged or pushed into or through tissue fold Fvia needle pushrod or member 56 from its proximal end preferably locatedwithin handle 16. Needle 54 may define needle lumen 58 within whichdistal anchor 62 and/or proximal anchor 64 may be situated duringdeployment and positioning of the assembly. A single suture or flexibleelement 70 (or multiple suture elements) may connect proximal anchor 64and distal anchor 62 to one another. For instance, element 70 maycomprise various materials such as monofilament, multifilament, or anyother conventional suture material, elastic or elastomeric materials,e.g., rubber, etc.

Alternatively, metals which are biocompatible may also be utilized forsuture materials. For instance, sutures may be made from metals such asNitinol, stainless steels, Titanium, etc., provided that they are formedsuitably thin and flexible. Using metallic sutures with the anchoringmechanisms described herein may additionally provide several benefits.For example, use of metallic suture material may decrease anypossibilities of suture failure due to inadvertent cutting or shearingof the suture, it may provide a suture better able to withstand theacidic and basic environment of the gastrointestinal system, and it mayalso enhance imaging of the suture and anchor assembly if examined underconventional imaging systems such as X-rays, fluoroscopes, MRI, etc. Asused herein, suture 70 may encompass any of these materials or any othersuitable material which is also biocompatible.

Needle 54 may optionally define needle slot 60 along its length to allowsuture 70 to pass freely within and out of needle 54 when distal anchor62 is ejected from needle lumen 58. Alternatively, rather than utilizingneedle slot 60, needle 54 may define a solid structure with suture 70being passed into needle lumen 58 via the distal opening of needle 54.

The proximal end of suture 70 may pass slidingly through proximal anchor64 to terminate in suture loop 74 via cinching knot 72. Suture loop 74may be omitted and the proximal end of suture 70 may terminateproximally of the apparatus 10 within control handle 16, proximally ofcontrol handle 16, or at some point distally of control handle 16. Inthis variation, suture loop 74 may be provided to allow for a graspingor hooking tool to temporarily hold suture loop 74 for facilitating thecinching of proximal 64 and distal 62 anchors towards one another forretaining a configuration of tissue fold F, as described in furtherdetail below. Cinching knot 72 may also comprise a slidable knot whichmay be slid distally along suture 70 to lock or hold against proximalanchor 64 once the tissue fold F and anchors 62, 64 have been desirablypositioned and tensioned, as also described below in further detail.

After needle assembly 48 has been pushed distally out through launchtube opening 24 and penetrated into and/or through tissue fold F, asshown in FIG. 3B, anchor pushrod or member 68 may be actuated also viaits proximal end to eject distal anchor 62, as shown in FIG. 3C. Oncedistal anchor 62 has been ejected distally of tissue fold F, FIG. 3Dshows how needle 54 may be retracted back through tissue fold F byeither retracting needle 54 back within launch tube lumen 52 or bywithdrawing the entire anchor delivery assembly 50 proximally relativeto tissue fold F.

FIG. 3E shows that once needle 54 has been retracted, proximal anchor 64may then be ejected from launch tube 18 on a proximal side of tissuefold F. With both anchors 62, 64 disposed externally of launch tube 18and suture 70 connecting the two, proximal anchor 64 may be held againstthe distal end of launch tube 18 and urged into contact against tissuefold F, as shown in FIGS. 3F and 3G, respectively. As proximal anchor 64is urged against tissue fold F, proximal anchor 64 or a portion ofsuture 70 may be configured to provide any number of directionallytranslatable locking mechanisms which provide for movement of an anchoralong suture 70 in a first direction and preferably locks, inhibits, orprevents the reverse movement of the anchor back along suture 70. Inother alternatives, the anchors may simply be delivered through variouselongate hollow tubular members, e.g., a catheter, trocars, etc.

With respect to the anchor assemblies described herein, the types ofanchors shown and described are intended to be illustrative and are notlimited to the variations shown. For instance, several of the tissueanchor variations are shown as “T”-type anchors while other variationsare shown as reconfigurable “basket”-type anchors, which may generallycomprise a number of configurable struts or legs extending between atleast two collars or support members. Other variations of these or othertypes of anchors are also contemplated for use in an anchor assembly.Examples of anchors which may be utilized are disclosed in co-pendingU.S. patent application Ser. No. 10/612,170, filed Jul. 1, 2003, whichis incorporated herein by reference in its entirety. Moreover, a singletype of anchor may be used exclusively in an anchor assembly;alternatively, a combination of different anchor types may be used in ananchor assembly. Furthermore, the different types of cinching or lockingmechanisms are not intended to be limited to any of the particularvariations shown and described but may be utilized in any of thecombinations or varying types of anchors as practicable.

To accomplish the secure placement of anchors having uni-directionalanchor movement over the suture in a self-locking manner, variousdevices and methods may be utilized. FIGS. 4A and 4B show side and endviews, respectively, of one anchor variation 80 which is illustrated inthe form of a T-type anchor. Although a T-type anchor is shown, themethods and devices used to cinch the anchor may be utilized in othertypes of anchors, which will be described below. Variation 80 maygenerally comprise an anchor body 82 having a circular, rectangular,square, etc., cross-section which defines openings 84 and 86 on opposingsides of the anchor 80. Locking block or member 88 may be slidablydisposed within anchor body 82 and define a tapered face 90 on the sideof block 88 which tapers to at least one of the openings, in this caseopening 86. Openings 84, 86 are preferably aligned with one anotheralthough this is not necessary.

Suture 94 may be routed through opening 84, around locking block 88, andback out through opening 86 such that when anchor body 82 is translatedin the direction of arrow 96, anchor body 82 may slide freely oversuture 94 due to the manner of tapered face 90 contacting suture 84within opening 84. However, if anchor body 82 were translated in theopposite direction, tension within suture 94 may pull locking block 88via suture 94 placed over contact surface 92 such that when block 88translates in the direction of arrow 98, suture 94 at opening 86 isforced into groove 100 defined along the leading edge of block 88, asshown in FIG. 4B. This cleating action may effectively inhibit orprevent any further movement of anchor body 82 over suture 94.Accordingly, anchor body 82 may be moved uni-directionally relative tosuture 94 and a distally located anchor to effectively cinch tissuetherebetween.

FIG. 5 illustrates another cinching anchor in the side view of anchorvariation 110. In this variation, anchor body 112 similarly definesopenings 114 and 116 through which suture 96 may be routed. Lockingblock or member 118, which may similarly also define tapered face 120may be slidably disposed within anchor body 112. Locking block 118 maybe urged via a biasing member, for instance spring 122, to maintain abiasing force against suture 94 passing through anchor body 112. Asanchor body 112 is translated over suture 94 in the direction of arrow96, tapered face 120 may allow suture 94 to pass freely between openings114, 116. However, if anchor body 112 were to be moved in the oppositedirection, biasing member 122 may force locking block 118 to exert aforce at its leading edge against suture 94, thereby preventing itsmovement and allowing only uni-directional movement.

Yet another locking anchor variation 130 is shown in the side view inFIG. 6. In this variation, anchor body 132 also defines openings 134,136 through which suture 94 may pass. Within anchor body 132, multiplelocking blocks or members 138, 140 may be configured to become biased inopposing directions via biasing members or springs 142, 144,respectively. Each of locking blocks 138, 140 may define an openingthrough which suture 94 may pass. Thus, when anchor body 132 is slowlymoved over suture 94 in a first direction, the anchor may translatefreely. However, when moved quickly in the opposite direction, thebiasing members 142, 144 may urge their respective locking blocks 138,140 in directions 146, 148 to create a tortuous path through the blocksand inhibit or prevent the reverse movement of anchor body 132 relativeto suture 94.

FIG. 7 shows a perspective view of another locking anchor variation 150in which anchor body 152 defines an opening 154 having a tapered orgrooved portion 156. Opening 154 may be sized to allow suture 94 to passthrough opening 154 such that anchor body 152 may be translated freelyrelative to suture 94. Once anchor body 152 has been desirablypositioned relative to the tissue fold or to the opposing anchor, suture94 may be manipulated to slide into tapered or grooved portion 156,which preferably defines a diameter which is less than a diameter ofsuture 94. Sliding suture 94 into tapered or grooved portion 156 maylock a position of anchor body 152 relative to suture 94 due to thecleating effect of grooved portion 156 on suture 94.

FIGS. 8A and 8B show cross-sectional side and top views, respectively,of another locking anchor variation 160 in which anchor body 162 maydefine a through-hole passage or opening 164 through which suture 94 maypass. Anchor body 162 may have one or several levered, flapped, orbiased locking members 166 which may be integrally formed with anchorbody 162. These locking members 166 may be formed radially about opening164 such that when suture 94 is absent, the resting configuration oflocking members 166 define an opening 164 having a diameter less thanthat of the suture 94 passed through. Locking members 166 may be biasedto protrude in a single direction, as shown in FIG. 8A, such that whenanchor body 162 is moved in a first direction over suture 94, the anchor162 passes freely. However, when anchor body 162 is moved in theopposing direction over suture 94, locking members 166 engage ontosuture 94 and prevent any reverse translation, thereby enablinguni-directional movement and locking of anchor body 162. Although fivelocking members 166 are shown, any number of members may be utilized aspracticable and as desired to effect a desired degree to locking.

FIG. 8C shows a cross-sectional side view of anchor body 162 incombination with a modified suture 168 having integrated features orprotrusions 170 defined along its length. Features or protrusions 170may be defined uniformly at regular intervals along the length of suture168 or intermittently, depending upon the desired effects, to enhancethe locking ability of the anchor body onto the suture. Moreover, thefeatures or protrusions 170 may be integrally formed protrusions or theymay simply comprise knotted sections of suture. Sutures which aremodified or knotted may be optionally utilized in any of the lockinganchor variations as described herein in place of conventional sutures,depending upon the desired degree of locking and locking effects.

As shown in the cross-sectional views of FIGS. 9A and 9B of lockinganchor variations 180 and 188, respectively, anchor body 182 may alsocomprise biased locking members 184, contained within the anchor body182. The number and configuration of locking members 184 may be variedas desired and may optionally be apposed, as shown in FIG. 9A, orutilize a single member 184, as shown in anchor variation 188 in FIG.9B. The figures show knotted suture 186 used with anchor variation 180;however, conventional sutures may also be utilized.

FIG. 9C shows another modification of suture 94 which may be utilizedwith any of the anchor locking variations shown herein. The portions ofsuture 94 which come into contact with the anchor locking mechanisms maybe coated with a material having a relatively higher frictionalcoefficient, i.e., a coefficient of friction that is higher than theunderlying suture material. For example, the portion of suture 94 may becoated with a metallic covering or slid within sleeve 181, which may bemade of a metallic material such as Titanium, Nitinol, stainless steel,etc. to enhance the locking force between suture 94 and the anchor. Asshown in the figure, if sleeve 181 is utilized, the ends 183, 185 ofsleeve 181 may be crimped onto suture 94. One or several openings 187may also be defined along sleeve 181 to further enhance the lockingcapability between suture 94 and the locking mechanism.

Aside from the use of mechanical locking features integrated within orwith the anchor bodies, locking mechanisms may also utilize a variety ofknotting techniques. Conventional knots, which are typically tied by thepractitioner either within the body or outside the body and advancedover the suture length, may be utilized for locking the anchor in placerelative to the tissue fold and opposing anchor; however, self-lockingknots which enable the uni-directional travel of an anchor body relativeto the suture and tissue are desirable.

FIG. 10 shows locking anchor assembly 190 with distal anchor 192, whichmay be positioned distally of a tissue fold, and proximal anchor 194,which may be positioned proximally of a tissue fold or folds. In thisvariation, suture 94 may be routed through proximal anchor 194 viaopenings 196, 198 and extended to distal anchor 192. At distal anchor192, suture 94 may be routed through opening 200 and over pin 202positioned within distal anchor 192. Pin 202 may function as a pulleyover which suture 94 may travel during anchor locking adjustments.Suture 94 may then be routed back towards proximal anchor 194 throughopening 204 and define loop 206 through which the proximal portion ofsuture 94 passes to thereby create a choke-type loop. The terminal endof suture 94 may then be anchored at fixed end 208 within the body ofproximal anchor 194.

In operation, when tension is applied to suture 94 or when proximalanchor 94 is advanced distally, proximal anchor 194 and distal anchor192 may be freely drawn towards one another to secure any tissue fold orfolds (not shown for clarity) disposed therebetween. However, ifproximal anchor 194 were pulled or urged in the opposite direction awayfrom the tissue or from distal anchor 192, loop 206 would “choke” suture94 and prevent any reverse movement of proximal anchor 194.

FIG. 11A shows a perspective view of locking anchor assembly 210 havingdistal anchor 212 and proximal anchor 214 with suture 94 extendingbetween the two anchors. Terminal end 230 of suture 94 may be knotted orotherwise retained by proximal anchor 214 and routed through opening 216and back through opening 218 to create looped portion 228, both openings216, 218 being defined in proximal anchor 214. Suture 94 may be routedfrom opening 218 and through distal anchor 212 via openings 222, 224.Suture 94 may then be routed back to proximal anchor 214 through anopening 220 and wrapped 226 about looped portion 228 to continue onproximally. This knotted configuration facilitates advancement ofproximal anchor 214 towards distal anchor 212 but chokes suture 94 whenproximal anchor 214 is moved in an opposing direction.

FIGS. 11B and 11C show top and cross-sectional side views of analternative variation on proximal anchor 214 (and distal anchor 212, ifdesired). As shown, anchor 214 may optionally define grooves or channels232 which extend at least partially between openings 216, 218, and 220.These grooves or channels 232, as seen in FIG. 11C, may be sized suchthat any of the overlying suture 94 are cinched or wedged into grooves232 to facilitate the cinching action of anchor 214 with respect tosuture 94.

Another locking anchor assembly 240 is shown in the perspective view ofFIG. 12A, which shows distal anchor 242 and proximal anchor 244 withsuture 94 extending between the two anchors. Suture 94 may be routedthrough opening 246 defined through proximal anchor 244 and passedthrough distal anchor 242 via openings 250, 252. Suture 94 may then berouted back towards proximal anchor 244 and passed through opening 248to create at least two adjacent loops (half hitch knots) 254, 256 withlooped section 258. During cinching of proximal anchor 244 against thetissue, the knotted suture may be slid distally with proximal anchor244. Once proximal anchor 244 has been desirably positioned along suture94, the terminal end of suture 94 may be pulled, as shown by arrow 260,to alter the knot configuration, commonly called changing the dressingof the knot, such that the knot becomes locked onto suture 94 andprevents any reverse movement of proximal anchor 244.

FIG. 12B also shows a perspective view of another locking anchorvariation similar to that shown in FIG. 12A. In this variation, suture94 may be wrapped into two intertwined loops 264, 266 and furtherwrapped again into adjacent intertwined loops 262, 268. Distaladvancement of the knotted configuration along with proximal anchor 244may be accomplished until the terminal end of suture 94 is placed undertension, as shown by arrow 260. Tension may be applied once proximalanchor 244 has been desirably positioned along suture 94 to lock theknot into position and prevent any reverse movement of proximal anchor244 along suture 94.

FIG. 12C shows a perspective view of another anchor locking assemblysimilar to the variations above. The knot may be modified by wrappingsuture 94 into a first set of several loops, shown as three loops 270,272, 274, although in other variations, any number of loops may beutilized depending upon the desired locking effects. Suture 94 may thenbe wrapped in a second set of several additional loops in a proximallyadjacent position about suture 94, shown as loops 278, 280, 282 joinedby looped section 276. Likewise, any number of loops in the second setmay be utilized either independent of the number of loops in the firstset or to mirror the first set of loops. In either situation, oncesuture terminal end 284 is tightened, a knotted configuration, as shownin FIG. 12D, is formed which may be freely slid along suture 94 providedthe knotted configuration itself is pushed along suture 94, e.g., via apusher tube, knot pusher, etc. However, once tension is applied alongsuture 94 by proximal anchor 244 pushing against the knot and by thetension created in the suture extending between anchors 242, 244, theknot locks against suture 94 and prevents reverse movement of proximalanchor 244 along suture 94.

FIG. 12E shows a perspective view of another locking anchor variationsimilar to the variation shown in FIG. 12D yet having a single suturetraverse between anchors 242, 244. In this variation, suture 94 may haveterminal end 286 anchored or retained by distal anchor 242 at opening252 and have a single suture traverse to proximal anchor 244. A secondterminal end 288 may also be anchored or retained by proximal anchor 244at opening 246. The portions of suture 94 extending between proximalanchor 244 and the knot may have a biasing member, e.g., spring 290,disposed over one or both lengths of suture to maintain proximal anchor244 and the knot under a constant force to ensure that the knot ismaintained under a locking force to prevent the reverse travel ofproximal anchor 244.

Yet another variation of a locking anchor variation having a singlesuture traversing the anchors is shown in the perspective view of FIG.12F. A terminal end 252 of suture 94 may be anchored or retained atdistal anchor 242 and routed to proximal anchor 214 through opening 218.The length of suture 94 may form loop 292 on a first side of proximalanchor 214 and a second loop 296 on the opposite side of proximal anchor214 between openings 216, 220. Suture 94 may then be wrapped about loop292 via loop 294 on the first side to form an interlocking suture loop.This variation is also effective in allowing proximal anchor 214 totranslate over suture 94 towards the tissue and distal anchor 242 yetprevent reverse movement of proximal anchor 214 due to a choking actionby the intertwined suture loops on the proximal side of proximal anchor214.

FIG. 12G shows a perspective view of another locking anchor variationsimilar to that shown in FIG. 12F. Here, suture 94 may be routed throughopening 220 in proximal anchor 214 to form loop 292 before being passedthrough openings 218 and 216 and intertwining loop 294 through loop 292.Likewise, this variation is also effective in allowing proximal anchor214 to translate over suture 94 towards the tissue and distal anchor 242yet prevent reverse movement of proximal anchor 214.

As mentioned above, the locking and cinching mechanisms described hereinmay be utilized with a variety of different anchor types. For instance,the cinching mechanisms described above may be used not only with T-typeanchors but also with reconfigurable basket-type anchors. Describedhereinafter are basket-type anchors configured for implantation orplacement against tissue in a similar manner as described previously andexamples of how cinching mechanisms may be utilized in securing tissueplications. Moreover, additional cinching mechanisms which arepreferably utilizable with basket-type anchors are also described below.

When cinching or locking basket-type anchors, the baskets may bedelivered into or through the tissue in the same or similar manner asdescribed above, particularly as shown in FIGS. 3A-3G. For example, FIG.13A shows anchor delivery system 300 in proximity to tissue fold F.Again, tissue fold F may be disposed within a gastrointestinal lumen,such as the stomach, where tissue wall W may define the outer or serosallayer of the stomach. Delivery push tube or catheter 302 may be disposedwithin launch tube 18 proximally of basket anchor 306, which is shown ina compressed delivery configuration with a relatively low profile whendisposed within needle lumen 58 of needle 54. A single basket anchor 306is shown disposed within needle 54 only for illustrative purposes and isnot intended to be limited by the number of basket anchors; rather, anynumber of basket anchors may be disposed within needle lumen 58 aspracticable depending upon the desired procedure and anchoring results.

Suture 94 may be routed through or externally of push tube lumen 304 andfurther routed within and/or through proximal collar 310 of anchor 306.The terminal end of suture 94 may be routed within anchor 306 andaffixed to distal collar 308 in one variation. Alternatively, suture 94may be affixed or anchored within anchor 306 or at proximal collar 310depending upon the desired effect and procedure being performed.Moreover, if multiple anchors are utilized in a tissue plicationprocedure, suture 94 may be routed through anchor 306 such that theanchor 306 may freely slide along or over suture 94.

The basket anchors may comprise various configurations suitable forimplantation within a body lumen. Basket anchors are preferablyreconfigurable from a low profile delivery configuration to a radiallyexpanded deployment configuration in which a number of struts, arms, ormesh elements may radially extend once released from launch tube 18 orneedle 54. Materials having shape memory or superelastic characteristicsor which are biased to reconfigure when unconstrained are preferablyused, e.g., spring stainless steels, Ni—Ti alloys such as Nitinol, etc.The basket anchor 306 is illustrated as having a number ofreconfigurable struts or arm members 312 extending between distal collar306 and proximal collar 310; however, this is intended only to beillustrative and suitable basket anchors are not intended to be limitedto baskets only having struts or arms. Examples of suitable anchors arefurther described in detail in U.S. patent application Ser. No.10/612,170, which has already been incorporated herein above.

FIG. 13A shows basket anchor 306 delivered through tissue fold F vianeedle 54 and launch tube 18. As above, the other parts of the plicationassembly, such as upper and lower bail members 20, 26, respectively, andtissue acquisition member 28 have been omitted from these figures onlyfor clarity.

FIG. 13B shows one variation where a single fold F may be secured usingbasket anchor 306′. As seen, basket anchor 306′ has been urged orejected from needle 54 and is shown in its radially expanded profile forplacement against the tissue surface. In such a case, a terminal end ofsuture 94 may be anchored within the distal collar of anchor 306′ androuted through tissue fold F and through, or at least partially through,proximal anchor 318, where suture 94 may be cinched or locked proximallyof, within, or at proximal anchor 318 via any number of cinchingmechanisms 316 described herein. Proximal anchor 318 is also shown in aradially expanded profile contacting tissue fold F along tissue contactregion 314. Locking or cinching of suture 94 proximally of proximalanchor 318 enables the adequate securement of tissue fold F.

If additional tissue folds are plicated for securement, distal basketanchor 306 may be disposed distally of at least one additional tissuefold F′, as shown in FIG. 13B, while proximal anchor 318 may be disposedproximally of tissue fold F. As above, suture 94 may be similarlyaffixed within distal anchor 306 and routed through proximal anchor 318,where suture 94 may be cinched or locked via proximal anchor 318, asnecessary. If tissue folds F and F′ are to be positioned into appositionwith one another, distal basket anchor 306 and proximal anchor 318 maybe approximated towards one another. As described above, proximal anchor318 is preferably configured to allow suture 94 to pass freelytherethrough during the anchor approximation. However, proximal anchor318 is also preferably configured to prevent or inhibit the reversetranslation of suture 94 through proximal anchor 318 by enablinguni-directional travel of anchor 318 over suture 94. This cinchingfeature thereby allows for the automated locking of anchors 306, 318relative to one another during anchor approximation.

Aside from the anchor cinching or locking mechanisms utilizing loopedand knotted sutures for facilitating uni-directional locking, variousmechanisms utilizing friction may also be implemented. FIGS. 14A and 14Bshow cross-sectional side views of one variation in cinching assembly320. Proximal collar 322, proximal portions of struts 312, and distalportions of launch tube 18 are shown and other features of the assemblyand tissue fold F have been omitted from the figure only for clarity.

A locking or cinching collar or collet 326 may be positioned withinlaunch tube 18 proximally of anchor collar 322. Cinching collet 326 maycomprise a cylindrically shaped member defining a lumen therethrough forpassage of suture 94. A distal end of cinching collet 326 may have atleast one and preferably several clamping arms or teeth 328 which areconfigured to cinch or clamp down upon suture 94 passing through.Proximal anchor collar 322 may be sized to correspondingly receivecinching collet 326 therewithin to create an interference fit. relativeto an outer diameter of cinching collet 326. A distal portion of anchorcollar 322 may also define a tapered or angled portion 324 such thatwhen cinching collet 326 is advanced within anchor collar 322, angledportion 324 may effectively force clamping arms or teeth 328 to cinchradially inward upon suture 94.

In operation, once proximal anchor 318 has been desirably positionedrelative to tissue fold F and/or the distal anchor and with proximalcollar 322 positioned within launch tube 18, delivery push tube 302 maybe advanced distally to urge cinching collet 326 into anchor collar 322such that clamping arms or teeth 328 are clamped onto suture 94 andcinching collet 326 is friction-fitted within anchor collar 322. Anchorcollar 322 may then be urged out of launch tube 18 and the anchor leftagainst the tissue surface.

Another cinching assembly variation 330 is shown in the cross-sectionview of FIGS. 15A and 15C. Launch tube 18 has been omitted from thesefigures for clarity only. Delivery push tube 332 is shown as definingsuture lumen 334 and locking member or pin lumen 336 therethrough.Although two separate lumens are shown, a single common lumen may beutilized in alternative variations. With proximal anchor collar 344positioned distally of push tube 332, suture 94 may be routed throughsuture lumen 334 and through collar lumen 346. Locking member or pin 338may be positioned within lumen 336 proximally of collar lumen 326. FIG.15B shows an end view of push tube 332 with locking pin 338 and suture94 positioned within prior to cinching of the anchor.

Once the anchor has been desirably positioned relative to the tissue,suture 94 may be pulled proximally such that anchor collar 344 restsagainst the distal end of push tube 332. Locking pin 338, which maydefine a tapered or radiused end 340 to facilitate its insertion intocollar lumen 346, may be urged distally via push rod 342 to forcelocking pin 338 into anchor collar 344 such that the portion of suture94 within anchor collar 344 becomes effectively wedged and therebyprevents further movement of the anchor along suture 94. FIG. 15C showsa cross-sectional side view of locking pin 388 having been urged intoanchor collar 344 in a frictional engagement with suture 94. FIG. 15Dshows a cross-sectional end view of collar 344 with locking pin 388 andsuture 94 positioned within.

FIG. 15E shows a perspective view of another cinching variation 331which is similar to the variation described above. One or more taperedpins or blocks 339 may be slidably disposed within tapered channel 335defined in proximal collar 333. The figure shows two tapered pins 339,although a single pin may be utilized or more than two pins may also beused. If two or more pins 339 are utilized, suture 94 may be passedbetween the pins 339. Pins 339 may be free to slide along inner surface337 of channel 335 in the direction of arrows 345 depending upon thedirection of travel of suture 94 through channel 335. FIG. 15F shows aperspective view of only pins 339 for clarity; as seen, pins 339 may betapered distally from a larger diameter to a smaller diameter andalthough pins 339 are shown as semi-circularly shaped members, contactsurface 341 may be curved or arcuate to better contact suture 94.Moreover, contact surface 341, which contacts suture 94 passing throughchannel 335, may define a roughened surface or it may alternativelydefine a plurality of serrations, teeth, projections, etc., tofacilitate contact against suture 94.

In use, as proximal collar 333 is translated in the direction of arrow343, pins 339 may be forced proximally such that suture 94 may passfreely through channel 335. However, if proximal collar 333 were to betranslated in the opposing direction, pins 339 may be forced in theopposite direction to cinch down upon suture 94 within channel 335 andthereby inhibit any further motion.

An alternative variation of the assembly is shown in the cross-sectionalviews of FIGS. 15G and 15H, which show a cinching anchor having aretractable pin. FIG. 15G shows proximal collar 347 with one or moreretracting arms 349 extending proximally from collar 347. Retractingarms 349 may be configured to pivot at bend 353 when urged via acompression force applied at bend 353 in the direction of arrows 355.The application of this compression force may urge pin support collar357 which is defined at a proximal portion of arms 349, to move in thedirection of arrow 359. This in turn may move pin 351, which extendsfrom pin support collar 357, proximally out of proximal collar 347 tothereby release suture 94 from its locked position. In one variation,retracting arms 349 may be biased to retain pin 351 within proximalcollar 347 unless a compression force is applied at bend 353.

FIGS. 16A and 16B show cross-sectional side views of another variationof cinching assembly 350. Cinching assembly 350 may generally compriseouter tubing 352 and inner tubing 358 rotatingly positioned within outertubing lumen 354. Cinching member 362 may be positioned distally ofouter tubing 352 and may generally comprise a collar base 364 andcinching collar 374 projecting proximally from collar base 364. Cinchingcollar 374 is preferably tapered and threaded and may also belongitudinally slotted such that rotatable collar 368 may be rotatinglydisposed upon slotted cinching collar 374. A distal end of outer tubing352 may define one or several engaging members 356 which are adapted toengagingly contact detents or keyed engagement interfaces 366 located oncollar base 364. Inner tubing 358 may also define one or severalengaging members 363 which are also adapted to engagingly contactdetents or keyed engagement interfaces 372 located on the rotatablecinching collar 374. Suture 94 may be routed through inner tubing lumen360, through cinching collar 374, and through proximal anchor collar310.

In operation, suture 94 may pass freely through assembly 350. Once theanchor has been desirably positioned, engaging members 356 on outertubing 352 may be correspondingly engaged against interface 366 andengaging members 363 on inner tubing 358 may be engaged againstinterface 372. With suture 94 tensioned appropriately, outer tubing 352may be held stationary while inner tubing 358 is rotated to torquerotatable collar 368 about threaded cinching collar 374. As rotatablecollar 368 is torqued onto cinching collar 374, the tapered shape mayurge the slotted members to cinch upon suture 94 passing therethrough.Stand-offs 370, which may protrude from rotatable collar 368, may beadjusted in height to control how far rotatable collar 368 may betorqued onto collar base 364 such that the degree to which rotatablecollar 368 is torqued about cinching collar 374 may be desirablyadjusted. Once the cinching collar 374 has been desirably cinched ontosuture 94, proximal anchor collar 310 may be ejected from launch tube 18along with the cinching assembly, as shown in FIG. 16B.

Another variation on cinching assembly 380 may be seen in thecross-sectional views of FIGS. 17A and 17B. Assembly 380 is similar tocinching assembly 330 shown above in FIGS. 15A to 15D. Delivery pushtube 332 and push rod 342 have been omitted from these figures only forclarity. In this variation, when locking pin 338 is pushed distally intoproximal collar 388, a retaining tube member 384 may be utilized toprovide a counterforce to stabilize proximal collar 388 during cinching.Retaining tube member 384 may generally comprise one or several collarengaging arms 386 for engaging proximal anchor collar 388 at collardetents 390 defined along anchor collar 388. During the insertion oflocking pin 338 into collar 388, collar engaging arms 386 may bepositioned within launch tube 18 or within retractable sleeve 382. Afterlocking pin 338 has been inserted within anchor collar 388, engagingarms 386 may be advanced distally out of launch tube 18 or retractablesleeve 382 may be withdrawn proximally to expose engaging arms 386. Oncefree of any constraining forces, engaging arms 386 may be biased tospring or open radially to then release proximal anchor collar 388 in acinched configuration.

Another variation on cinching assembly 400 is shown in FIGS. 18A to 18D,in which proximal anchor collar 406 may comprise one or several biasingmembers or cinching tabs 408 within collar 406. Each of the tabs 406 maybe biased to project inwardly such that suture 94 passing through isautomatically cinched and locked in position, as shown in FIG. 18A. Asuture release member 404, which may generally comprise a cylindricallyshaped tube or member having a tapered surface 410 and a suture lumen412 defined therethrough, may be positioned within anchor collar 406during anchor positioning to allow free passage of suture 94 through theanchor, as shown in FIG. 18B. FIG. 18C shows an end view of releasemember 404 defining suture lumen 412 extending therethrough. FIG. 18Dshows a perspective view of release member 404 to show tapered surface410 and suture lumen 412 in better detail. Tapered surface 410 may beomitted but is preferably to facilitate the insertion and removal ofrelease member 404 from anchor collar 406. When the anchor has beendesirably positioned and is ready to be locked in place over suture 94,tubular member 402 may engage suture release member 404 for withdrawalfrom anchor collar 406. The removal of release member 404 may causecinching tabs 408 to lock upon suture 94 and prevent the furthermovement of the anchor relative to suture 94.

FIGS. 19A and 19B show another variation of cinching assembly 420 inwhich a deformable cinching member 424 may be positioned within theanchor distally of anchor collar 422. Cinching member 424 may define atapered outer surface such that when the anchor is ready to be securedto suture 94, the insertion of cinching member 424 into collar 422 maycompress cinching member 424 about suture 94 such that any furthermovement of the anchor is prevented. Cinching member 424 may be pulledinto anchor collar 422 via pull wire 426, which may be manipulated atits proximal end by the surgeon or user when desired.

FIGS. 20A to 20D show cross-sectional views of another variation incinching assembly 430. As shown in FIG. 20A, proximal anchor collar 432may comprise a pivotable locking member 434 contained either withinanchor collar 432 or proximally of collar 432. This example illustrateslocking member 434 contained within collar 432. Suture 94 may passthrough locking member 434, which is shown in the end view of collar 432in FIG. 20B, as having two pivots 436. Moreover, locking member 434 andpivots 436 may be integrally formed from proximal collar 432. Pivotinglocking member 434 may be biased to rotate about pivot 436 such that aresting position of locking member 434 is against an inner surface ofcollar 432. During distal anchor translation over suture 94, tension asrepresented by arrow 438, on suture 94 may force pivot 434 into an openposition where suture 94 may pass freely through. Upon having desirablypositioned the anchor against tissue, locking member 436 may be biasedto pivot in direction 440 to lock suture 94 against the inner surface ofcollar 432. Opposite movement of the anchor relative to suture 94 mayact to further cinch locking member 434 against suture 94 and therebyfurther inhibit the movement of the anchor in the reverse direction.

A similar variation is shown in the cross-sectional side and perspectiveviews of FIGS. 20E and 20F, respectively. In this variation, lockingmember 434′ may extend proximally of proximal collar 432 at an anglerelative to collar 432. Locking member 434′ may be pivotable via pivot436′ such that locking member 434′ may pivot in the direction of thearrows shown depending upon the direction which the tissue anchor istranslated relative to suture 94. If proximal collar 432 is translateddistally over suture 94, it may travel freely; however, if proximalcollar 432 is translated proximally in the opposite direction, suture 94may become wedged in a tapered portion of opening 442 through whichsuture 94 passes. Once suture 94 is wedged in tapered opening 442,locking member 434′ may pivot towards proximal collar 432, where it isstopped from further motion, thereby locking the tissue anchor ontosuture 94 and preventing its reverse motion.

FIGS. 21A and 21B show another cinching assembly variation 450 as seenin the cross-sectional side views. In this variation, delivery push tube452 may be disposed proximally of locking collar 454 and proximaltapered anchor collar 458. Once the anchor has been desirably positionedrelative to the tissue fold F, with suture 94 under tension, lockingcollar 454 may be urged distally via push tube 452 such that lockingcollar 454 slides over proximal anchor collar 458. An inner surface oflocking collar 454 may be tapered and anchor collar 458 may also betapered in a correspondingly opposed manner such that when lockingcollar 454 is mated with anchor collar 458, anchor collar 458 may cinchlocking collar 454 upon suture 94 to thereby prevent any furthermovement of the anchor over suture 94. Both collars may be made from anyof the same or similar materials, as described above.

In addition to friction-based locking and cinching mechanisms utilizablein tissue anchors, other mechanisms which create tortuous paths for thesuture within or through the anchors may also be utilized for creatinguni-directional locking.

One cinching anchor variation 460 is shown in the cross-sectional sideview in FIG. 22A. As shown, suture 94 may be routed through anchorproximal collar 462 and looped over pulley or pin 466 contained withindistal collar 464. Suture 94 may then be routed back through and looped468 about suture 94 and tied with slip knot 470. As tension is appliedto suture 94, slip knot 470 may prevent further movement of the anchorrelative to suture 94.

FIGS. 22B and 22C show a variation which may be used in combination withcinching anchor variation 460 or alone. Pin 474 may optionally bepositioned within proximal collar 462 and suture 94 may be wrapped orlooped about itself around pin 474 in a manner as shown in the detailview of FIG. 22C. The configuration of loop 472 may allow for theuninhibited translation of the anchor in the direction of the arrow asshown; however, when the anchor is moved in the opposite direction, loop472 may effectively cinch upon itself to thus prevent or inhibit thereverse motion of the anchor relative to suture 94.

Another cinching variation is shown FIGS. 22D and 22E. Suture 94 may berouted through proximal collar 462 with an additional length of cinchingsuture 476. The distal end of cinching suture 476 may form loop 478which is wrapped about suture 94 and free to slide over suture 94. Afterthe anchor has been desirably positioned relative to the tissue and withsuture 94 preferably under tension, cinching suture 476 may be pulledproximally such that loop 478 is pulled into proximal collar 462 andbecomes wedged against suture 94. The multiple lengths of suturingmaterial utilized for loop 478 and suture 94 preferably form across-sectional area which is larger than an inner diameter of proximalcollar 462 such that positioning loop 478 and suture 94 within collar462 ensures a frictional lock which prevents further movement of thesuture 94 relative to the anchor. Suture 94 and cinching suture 476 arepreferably made from the same or similar materials although differingsuture materials may also be used.

FIG. 23 shows a cross-sectional view of cinching assembly variation 480in which proximal collar 482 may comprise pulley or pin 484 about whichsuture 94 may be looped once or several times 490. Distal collar 486 mayalso comprise pulley or pin 488 about which suture 94 may also be loopedonce or several times before being wrapped or looped 492 back aboutsuture 94. The terminal end of loop 492 may be secured about suture 94via slip knot 494. This configuration of looping allows for the anchorto be advanced uni-directionally relative to the suture and tissue, yetprevents or inhibits the reverse movement of the anchor and thuseffectively enables the tissue to be cinched via the anchors.

Another cinching or locking anchor variation 500 is shown in thecross-sectional view of FIG. 24A. In creating a tortuous path for suture94, cinching sleeve 506 may be positioned proximally of proximal collar504 within or distally of delivery push tube 502. Cinching sleeve 506may generally comprise a tubular structure having sleeve lumen 510defined therethrough and a number of openings 508 defined along thelength of sleeve 506. Openings 508 may be uniformly patterned alongsleeve 506 or they may be randomly positioned. Moreover, any number ofopenings 508 may be utilized as practicable. In either case, suture 94may be routed in various patterns throughout openings 508 and throughsleeve lumen 510 before being routed through proximal collar 504. Oncethe anchor is to be locked, cinching sleeve 506 may be urged distallyvia delivery push tube 502. When urged or pushed distally, this may bedone slowly so as to allow suture 94 to pass through the tortuous pathcreated by suture 94 passing through openings 508. However, oncecinching sleeve 506 has been advanced proximally adjacent to proximalcollar 504, cinching sleeve 506 may become locked with proximal collar504 pressing against sleeve 506.

FIG. 24B shows another variation of a cinching mechanism which utilizesa tortuous path. Cinching sleeve 512 may comprise a tubular structurehaving an opening 514 defined along a surface of sleeve 512 throughwhich suture 94 may pass. Cinching sleeve 512 may be disposed withinproximal collar 504 with suture 94 routed from outside of sleeve 512 andpassing to within sleeve 512 through opening 514. In operation, becauseof the manner in which suture 94 is routed through sleeve 512 and intothe anchor, distal translation of the anchor relative to the tissue andsuture 94 is uninhibited. But when the anchor is reversed in directionrelative to suture 94, suture 94 and cinching sleeve 512 may be drawninto the anchor and become locked due to the interference between suture94, cinching sleeve 512, and proximal collar 504. Accordingly, an outerdiameter of cinching sleeve 512 is preferably sized to be slightly lessthan an inner diameter of proximal collar 504 such that when suture 94is passed through opening 514, cinching sleeve 512 becomes wedgedagainst collar 504. Cinching sleeve 512 may be made from any of the sameor similar materials as the anchors, as described above.

FIGS. 24C and 24D show another variation similar to cinching sleeve 512described above. Cinching sleeve variation 516 may be similarly sized assleeve 512 and may also similarly define an opening 514; however, sleeve516 includes one or several retaining arms 518 defined on a distal endof sleeve 516. Any number of retaining arms 518 may be utilized providedthat they extend radially and reside distally of proximal collar 504such that they prevent sleeve 516 from sliding proximally out of collar504. FIG. 24D shows a perspective view of cinching sleeve 516 withretaining arms 518 radially extended from the body of sleeve 516.Cinching sleeve 516 may also be made from the same or similar materialas the anchor; for example, sleeve 516 may be fabricated from a materialhaving superelastic characteristics, such as Nitinol. Accordingly, whencinching sleeve 516 is initially inserted through collar 504 and/orduring anchor delivery through launch tube 18 into or through thetissue, retaining arm or arms 518 may be configured into a low profilewith arm or arms 518 constrained into a tubular shape. Upon anchorrelease or upon being inserted through collar 504, retaining arms 518may be released to extend radially.

Yet another variation 520 on cinching assembly is shown in FIG. 25A.Generally, assembly variation 520 may comprise cinching collar 522located proximally of anchor proximal collar 524. Cinching collar 522may be a tubular structure having superelastic material characteristics,such as those found in Nitinol. Obstructing members 526, which may beformed from portions of cinching collar 522, may be pressed or formed toextend into a lumen of cinching collar 522 such that a tortuous path iscreated for the passage of suture 94. Although three obstructing members526 are shown in the figure, any number of obstructions as practicablemay be created depending upon the desired tortuous path to be created.

Assembly 520 shows cinching collar 522 as a separate collar locatedproximally of anchor collar 524; however, the cinching collar may beintegrated with the anchor collar such that a singular integralstructure is formed, as shown in anchor variation 530 in thecross-sectional view of FIG. 25B. In either alternative during anchorplacement relative to the tissue fold, retaining sleeve 534 may beinserted within cinching collar 522 to maintain obstructing members 526in an open position for allowing suture 94 to pass freely through sleeve534. Once the anchor has been desirably positioned, retaining sleeve 534may be withdrawn, as shown in the perspective view of FIG. 25C, usingany number of methods. Removal of retaining sleeve 534 will allow forobstructing members 526 to reconfigure inwardly in the direction ofarrows 532 to thus reconfigure cinching collar 522 into a tortuous path.

Cinching assembly 540 may also utilize a single or any number of tabs orlevers to aid in capturing suture 94 and/or creating a tortuous path forsuture 94 to traverse. As shown in the cross-sectional view of FIG. 26A,proximal collar 542 may have a pivoting lever 544 formed integrally froma side wall of proximal collar 542. Alternatively, lever 544 may beincluded in a cinching collar separate from proximal collar 542. Lever544 may be biased to spring inwardly into proximal collar 542 uponsuture 94 passing therethrough. During translation of the anchor in afirst direction, suture 94 may be allowed to freely pass throughproximal collar 542 and past lever 544 due to its pivoting motion. Whenthe anchor is moved or urged in the reverse direction, lever 544 may actto cinch down upon suture 54 against an inner surface of proximal collar542, as shown in the figure.

Another variation 546 of assembly 540 is shown in the cross-sectionalview of FIG. 26B in which proximal collar 548 is shown as having atleast two levers 550, 552 both biased in opposing directions to create atortuous path for suture 94 to traverse. In either variation, thecinching levers may be configured to prevent or inhibit theover-cinching or cutting of suture 94. FIGS. 26C and 26D showalternative end views of FIG. 26A. Uni-directional lever 544, as seen inFIG. 26C, may be formed from the side wall of proximal collar 542 suchthat when lever 544 cinches down upon suture 94, the corners or ends oflever 544 contact an inner surface of proximal collar 542 at contactpoints 554. The contact which occurs may ensure that an open space 556is preserved and that lever 544 is prevented from over cinching ontosuture 94 within space 556 and cutting suture 94. FIG. 26D shows analternative uni-directional lever 544′ which defines a curved or arcuateedge 558 which contacts suture 94. The arcuate edge 558 may prevent theover cinching onto suture 94 and cutting of suture 94.

FIGS. 26E, 26F, and 26G show alternative variations of cinching assembly546 with uni-directional levers having various configurations. FIG. 26Eshows a cross-sectional side view of cinching assembly 560 in whichproximal collar 562 may have levers 564, 566 directed and biased inopposing directions to create a tortuous path. Each of the levers 564,566 in this variation may be curved inwardly towards proximal collar562. FIG. 26F shows a cross-sectional side view of cinching assembly 568in which proximal collar 570 has uni-directional levers 572, 574 angledtowards on another when biased inwardly. And FIG. 26G shows across-sectional side view of cinching assembly 576 in which proximalcollar 578 has uni-directional levers 580, 582 curved outwardly relativeto one another when the levers are biased within collar 578.

FIGS. 27A and 27B shows yet another variation of cinching assembly 590which utilizes a reconfigurable hollow member for cinching suture 94. Asshown in FIG. 27A, hollow member 594 may be constrained within tubulardelivery member 592 to retain an elongate shape with suture 94 passinguninhibited therethrough. When the anchor is to be cinched, hollowmember 594 may be advanced distally from tubular member 592 and whenhollow member 594 has been ejected, it may adapted to reconfigure itselfinto a crimped configuration 594′ having a non-linear passageway. Suture94 passing through the crimped configuration 594′ may be inhibited frompassing freely therethrough by crimp 596 created within the hollowmember. Hollow member 594 may have a variety of cross-sectional shapes,e.g., circular, rectangular, square, hexagonal, etc., and it ispreferably made from a material having shape memory characteristics,e.g., Nitinol, such that when hollow member 594 is unconstrained, it mayautomatically reconfigure into its crimped configuration 594′.

Another variation of cinching assembly 600 which is configured toreconfigure itself upon being unconstrained is shown in thecross-sectional views of FIGS. 28A to 28C. In this variation shown inFIG. 28A, cinching collar 602 may comprise at least two circularmembers, first collar 606 and second collar 608, connected by anelongate bridging member 604. Cinching collar 602 may be positionedwithin launch tube 18 proximally adjacent to proximal collar 610 andadapted to reconfigure itself once released from launch tube 18 suchthat a tortuous path is created for suture 94. FIG. 28B shows analternative variation in the cinching collar which may be an integratedvariation with the proximal collar such that first collar 606 isconnected directly to the anchor via joining member 612. In eithervariation, once the cinching collar has been ejected from launch tube18, the collar may configure itself such that first collar 606 andsecond collar 608 are biased towards one another to form, e.g., a“C”-shape as shown in FIG. 28C. The tortuous path which is created bycinching collar 602 for suture 94 to follow may be sufficient to preventthe further translation of the anchor relative to suture 94. FIGS. 28Dand 28E, respectively, show perspective views of cinching collar 602 ina constrained delivery configuration and an unconstrained cinchingconfiguration.

FIG. 28F shows a cross-sectional side view of another cinching assemblywhich is similar to the variation shown in FIG. 28B. Rather than havingfirst collar 606 and joining member 612 reconfigure itself into asemi-circular shape relative to the anchor, first collar 606 mayreconfigure itself to maintain its orientation relative to the anchorwhile joining member 612 may be formed to curve appropriately orapproximately in an “S”-type configuration. The reconfigured cinchingmember may act to lock suture 94 relative to the anchor when the anchoris moved in a reverse direction.

Another configuration for a cinching assembly is shown in the side viewof FIG. 28G, which shows cinching member 616 located proximally ofproximal collar 614. Cinching member 616 may be fabricated from avariety of materials, e.g., Nitinol, spring stainless steel, etc., whichexhibit shape memory or superelastic characteristics, or aspectsthereof. In use, cinching member 616 may be configured into an elongatedelivery configuration. When the tissue anchor is to be cinched orlocked relative to the tissue, cinching member 616 may be released froma constraining force such that cinching member 616 reconfigures itselfinto an expanded or extended configuration which creates a tortuous pathfor suture 94 which sufficiently locks suture 94 within cinching member616.

Cinching member 616 may be comprised generally of an elongate bar,ribbon, cylinder, etc., or any elongate member having a diameter orcross-sectional area in its delivery configuration which is sufficientlysmall to be disposed and/or translated within launch tube 18. Cinchingmember 616 may define a plurality of openings 618 along the length ofcinching member 616 such that when cinching member 616 is in itselongate delivery configuration, as shown in FIG. 28G, suture 94 may beinterwoven through openings 618 along a relatively straightened path.Openings 618 may be located along cinching member 616 at uniformlocations or they may be randomly positioned along the length ofcinching member 616. When released, cinching member 616 may reconfigureitself into an expanded suture-locking configuration 616′ which issufficiently large to prohibit its passage into or through proximalcollar 614, as shown in FIG. 28H. Expanded configuration 616′ maycomprise any reconfigured shape so long as the expanded shape is adaptedto create the tortuous path for suture 94 and is large enough so thatpassage through proximal collar 614 is not possible.

Other cinching and locking mechanisms which utilize mechanical clampingor crimping to achieve locking of the suture within or through theanchors may also be used to facilitate uni-directional locking.

For instance, cinching assembly 620 may be seen in the cross-sectionalview of FIGS. 29A and 29B. FIG. 29A shows delivery tube member 622having crimping collar 624 disposed therewithin proximally of anchorproximal collar 626. Suture 94 may be passed through both crimpingcollar 624 and proximal collar 626. Once the anchor has been desirablypositioned, crimping collar 624 may be advanced distally adjacent toproximal collar 624 and mechanically crimped 624′ down upon suture 94 tocreate a lock and prevent the reverse movement of the anchor over suture94, as shown in FIG. 29B. The crimping may be accomplished viamechanical graspers or pinchers configured to clamp down upon collar624. Similarly, FIG. 30A shows cinching assembly 630 in which thecrimping collar 632 may be integral with the anchor rather than being aseparate member. FIG. 30B shows a mechanically crimped collar 632′ whicheliminates the need for a separate collar.

To accomplish mechanical crimping upon a cinching collar, variousmethods may be utilized. FIG. 31A shows one variation of a tool assembly640 which may be adapted to apply a mechanical crimping force upon acrimping collar. As seen, launch tube 18 may have delivery push tube 642located therewithin and positioned proximally of proximal collar 652 ofthe tissue anchor. Push tube 642 may be used to hold and/or ejectproximal collar 652 from launch tube 18. Crimping device 644 may beadvanced within launch tube 18 via crimping control member 646, whichmay be manipulated from its proximal end.

A collar retaining channel 650 may be defined in a distal end ofcrimping device 644 and adapted to receive and securely hold proximalcollar 652 within during a clamping or crimping process. Crimpingmembers or arms 648 may be positioned within crimping device 644 oneither side of retaining channel 650. When proximal collar 652 orcrimping sleeve is to be clamped or crimped, crimping members or arms648 may be driven into contact with proximal collar 652 to crimp thecollar. Moreover, crimping arms 648 may be actuated through a variety ofmethods, e.g., hydraulically, pneumatically, via mechanical leverage,etc.

An alternative crimping assembly 660 is shown in the cross-sectionalview of FIG. 32A. Crimping device 662 may be seen within launch tube 18extending from crimping control member 664. Collar retaining channel 672may be likewise defined within crimping device 662 for retainingproximal collar 670 during a crimping procedure. This variation mayutilize a separate elongate crimping member 666 having actuatablecrimping arms 668 positioned at a distal end of elongate member 666. Inuse, with proximal anchor collar 670 positioned within retaining channel672, elongate member 666 may be advanced distally until crimping arms668 are positioned over proximal collar 670 and crimped down. FIG. 32Bshows an exploded perspective view of the crimping assembly.

FIGS. 31B to 31D show side, end, and perspective views, respectively, ofone variation of an anchor proximal collar 652 which is adapted forcrimping upon a suture passing therethrough. To facilitate crimping ofthe collar 652, a circumferential slot 656 may be defined through collar652 partially around its circumference. Another longitudinal slot 658may be defined through collar 652 extending longitudinally from aproximal edge of collar 652 to circumferential slot 656. These slots656, 658 may define at least two crimping arms 654 which may be crimpeddown upon a length of suture passing through collar 652.

Aside from the crimping mechanisms described above, additional measuresmay be optionally implemented to facilitate the cinching or locking ofan anchor. Other measures may also be taken to inhibit any damage fromoccurring to the suture routed through an anchor.

To ensure that the integrity of suture 94 is maintained in the presenceof metallic basket anchors 682 and to ensure that suture 94 is notsubjected to any nicks or cuts, the portion of suture 94 passing throughbasket anchor 682 may be encased in a protective sleeve 690, as shown inthe perspective view of FIG. 33A of anchor-sleeve assembly 680. Thebasket anchor 682 is shown in this variation as having anchor struts orarms 688 in a partially deployed configuration. Sleeve 690 may extendbetween distal collar 684 and proximal collar 686 to prevent excessivecontact between suture 94 and elements of basket anchor 682. FIG. 33Bshows an end view of the anchor-sleeve assembly 680 showing the relativepositioning of sleeve 690 relative to suture 94 and anchor collar 686.Sleeve 690 may be made from a variety of polymeric materials, e.g.,polypropylene, PTFE, etc., provided that the material is suitably soft.

FIG. 34A shows a cross-sectional view of cinching assembly 700 which maybe implemented with any of the cinching and locking mechanisms describedabove. This particular variation utilizes the partial cold-flowing ofthe engaged suture 94 to enhance the locking or cinching effect of thetissue anchor. The cinching collar, or in this variation proximal collar702, against which suture 94 is wedged may have multiple through-holes704 defined over the surface of collar 702. The cross-sectional sideview shows suture 94 wedged within collar 702 against locking pin 338.The portion of suture 94 which is adjacent to through-holes 704 may haveregions which cold-flow partially into through-holes 704, as shown bycold-flowed suture material 706. These portions of suture material 706may enhance the locking aspects of suture 94 against collar 702. FIG.34B shows a perspective view of collar 702 with multiple through-holes704 defined over the body of collar 702. Through-holes 704 may bedefined in a uniform pattern; alternatively, they may be randomlydefined over collar 702 or only over portions of collar 702.

FIGS. 35A to 35E show an alternative variation 710 for locking a tissueanchor relative to suture 94. An outer sleeve 720 which is preferablycomprised of a polymeric material capable of at least partially flowingwhen heated, e.g., PTFE, may be disposed circumferentially about anelectrically conductive inner sleeve 722. As shown in the perspectiveviews of FIGS. 35B and 35C, inner sleeve 722 may be disposed withinlumen 726 of outer sleeve 720. Inner sleeve 722 may randomly oruniformly define a plurality of openings or through-holes 724 over thesurface of inner sleeve 722.

In operation, outer and inner sleeves 720, 722, respectively, may bepositioned within delivery push tube 716 proximally of proximal collar718 with suture 94 passing therethrough. When the tissue anchor has beendesirably positioned and suture 94 has also been desirably tensioned, aninduction unit 712 having one or more induction coils 714 therewithinmay be positioned circumferentially (or at least partiallycircumferentially) about outer and inner sleeves 720, 722. Inductionunit 712 may be configured to be disposed within the launch tube 18 orit may be configured to be advanced over or positioned upon launch tube18. Thermal energy or electrical energy in various forms, e.g., RF,microwave, etc., may be delivered to induction coils 714 such that theenergy heats inner sleeve 722, which may be positioned within inductioncoils 714, as shown in FIG. 35A. As inner sleeve 722 is heated viainduction, the inner surface of outer sleeve 720 may be partially meltedor deformed such that the material flows at least partially through orwithin through-hole 724 and contacts suture 94 positioned within innersleeve 722. The flowed material may cool and act to lock outer and innersleeves 720, 722 onto suture 94. Induction unit 712 may then be removedfrom the area leaving outer and inner sleeves 720, 722 locked relativeto the tissue anchor.

Although inner sleeve 722 shows through-holes 724 as circularly definedopenings, other shapes may be utilized. For example, FIG. 35D shows aperspective view of one inner sleeve variation 728 having longitudinallydefined slots 730. Alternatively, FIG. 35E shows a perspective view ofanother inner sleeve variation 732 having circumferentially definedslots 734. Any variety of opening shapes may be utilized so long as theopening or openings allow for material from the outer sleeve 720 to flowthrough into contact with the suture positioned within.

Referring now to FIGS. 36 and 37, a cinching assembly comprising aninterference element is described. Cinching assembly 800 comprisestubular or hollow body member 802 having distal opening 804 and proximalopening 806. If body member 802 is tubularly or cylindrically shaped,the passage defined through body member 802 is preferably of a taperedor conical shape. Body member 802 may optionally be shaped into atapered or conical configuration. Distal opening 804 is sized forpassage of suture 808 therethrough, while proximal opening 806 is sizedfor passage of both the suture and interference element 810,illustratively a ball or sphere.

Assembly 800 further comprises proximal plug or cap 812 that is coupledto the proximal end of body member 802 and that fills proximal opening806 of the body member. Plug or cap 812 may be fitted or held withinbody member 802 through a variety of methods. For instance, plug or cap812 may be friction-fitted within the proximal opening 806.Alternatively, plug or cap 812 may be fitted via a circumferentialdetent configured to snap into place within the proximal opening 806;and in yet another example, plug or cap 812 may simply be held within oradjacent to proximal opening 806 via an adhesive. As best seen in FIG.37, plug 812 comprises through-hole 814 configured for passage of suture808 (for the purposes of illustration, suture 808 is not shown in FIG.37).

Ball 810 may, for example, have a diameter between about 0.020″ and0.040″, although any other diameter may be provided as desired.Furthermore, the ball may be fabricated from any of a variety ofmaterials, such as aluminum, titanium or steel; alternative materialswill be apparent. Suture 808 may, for example, have a nominal diameterof about 0.016″, although other diameters may be provided. Distalopening 804 of body member 802 and through-hole 814 of proximal plug 812may, for example, have a diameter of about 0.018″, although otherdiameters may be provided.

As illustrated by arrows in FIG. 36A, urging body member 802 distally,i.e., in the direction of the arrows shown, relative to suture 808 urgesball 810 towards the proximal end of body member 802 and against plug orcap 812. In this example, since the proximal end of the conical bodymember may have a larger cross-section than its tapered distal end,suture 808 may pass freely through cinching assembly 800, therebyallowing the suture to be cinched. As illustrated by arrows in FIG. 36B,moving body member 802 proximally relative to suture 808 urges ball 810towards the tapered distal end of body member 802. This interference orfriction locks suture 808 between ball 810 and the interior wall of bodymember 802, thereby allowing uni-directional cinching of assembly 800relative to suture 808 by locking cinching assembly 800 and preventingany reverse movement of suture cinching.

Referring now to FIG. 38, variations of cinching assembly 800 aredescribed. In the variation of FIG. 38A, conical body 802 has beenreplaced with tubular body 820 having tapered or profiled interior lumen821, which facilitates friction locking of suture 808 between ball 810and the profiled wall of the lumen. Body 820 may, for example, bemachined, cast or molded to achieve the profile of lumen 821. Proximalplug 812 illustratively comprises a hypotube concentrically disposedwithin body 820. Through-hole or lumen 814 of plug or hypotube 812 issized for passage of suture 808 therethrough, but is smaller than thediameter of ball 810 to prevent ball 810 from exiting or falling out ofbody 820.

FIG. 38B provides a similar variation of assembly 800 having body 820′with profiled interior lumen 821′. In contrast to the variation of FIG.38A, body 820′ may, for example, comprise a standard hypotube, while theprofile of lumen 821′ may be formed via secondary insert 822 disposedwithin the hypotube. Insert 822 may, for example, comprise epoxyinjected within the hypotube, or may comprise a separate piece that isfriction fit or otherwise fit within the hypotube.

In the variation of FIG. 38C, assembly 800 comprises tubular body 830having lumen 831, as well as end cap or plug 832 with proximal opening834 for passage of suture 808. The end cap may, for example, comprise abead of epoxy, while the tubular body may comprise a hypotube. Crimpedhypotube 840 is concentrically disposed over or within tubular body 830and is coupled to body 830 at attachment 842. Attachment 842 may, forexample, comprise a weld formed between the tubular body and thehypotube, or may comprise a glue attachment, such as a cyanoacrylateattachment, etc. Hypotube 840 further comprises central crimp 844. Thereduced diameter of lumen 841 through hypotube 840 in the vicinity ofcrimp 844 facilitates friction locking of ball 810 with suture 808 toprevent reversal of suture cinching.

In the variation of FIG. 38D, cinching assembly 800 is formed from threetubes, e.g., hypotubes. Proximal hypotube 860 is concentrically disposedwithin a proximal end of body hypotube 850, while distal hypotube 870 isdisposed within a distal end of the body hypotube. Body hypotube 850comprises lumen 851 configured for passage of ball 810 and suture 808therethrough; while proximal hypotube 860 comprises lumen 861, anddistal hypotube 870 comprises lumen 871, both of which are configuredfor passage of suture 808 therethrough, but not for passage of ball 810.Body hypotube 850 and distal hypotube 870 comprise crimp 880 thatlocally reduces lumens 851 and 871. As seen in FIG. 38D, the ball andsuture are disposed within lumen 851 in a manner that allows freeproximal movement of suture 808 relative to cinching assembly 800, butthat friction locks suture 808 between ball 810 and crimp 880 duringdistal movement of the suture relative to the assembly.

The cinching assembly variations of FIGS. 36-38 rely on an interferencefit and/or friction between a suture, thread or other flexible element;an interference element, such as a ball or sphere; and an interiorsurface of a body member element through which the flexible element andthe interference element pass. The material characteristics and/orsurface texture or roughness of these three elements may be specified toachieve, for example, desired frictional characteristics andinteractions, ease of cinch, locking forces, etc. Exemplary materialsand surface characteristics for any or all of the cinching assemblyelements include, but are not limited to, metals, polymers, elastomers,sandblasted metals, smooth metals, sapphire, glass, etc. Additionalmaterials and surface characteristics will be apparent to those of skillin the art.

Although a number of illustrative variations are described above, itwill be apparent to those skilled in the art that various changes andmodifications may be made thereto without departing from the scope ofthe invention. Moreover, although specific locking or cinchingconfigurations may be shown with various types of anchors, it isintended that the various locking or cinching configurations be utilizedwith the various types of anchors in various combinations aspracticable. It is intended in the appended claims to cover all suchchanges and modifications that fall within the true spirit and scope ofthe invention.

1. A surgical anchor assembly comprising: a first anchor; a sutureattached to the first anchor; a second anchor having a distal collarattached to a proximal collar by multiple struts, with the proximalcollar having two or more tapered pins in a tapered channel, and withthe suture extending through the tapered channel between the taperedpins.
 2. The surgical anchor assembly of claim 1 with the pins notattached to the second anchor.
 3. The surgical anchor assembly of claim1 wherein the struts are flexible.
 4. The surgical anchor assembly ofclaim 1 wherein the first anchor and the second anchor comprise basketanchors.
 5. The surgical anchor assembly of claim 4 with the firstanchor having a distal collar attached to a proximal collar by multiplestruts, and with the suture extending through the proximal collar andterminating at the distal collar of the first anchor.
 6. The surgicalanchor assembly of claim 1 with the suture extending along an axis andwith the tapered pins movable in a direction parallel to the axis withinthe tapered channel.
 7. The surgical anchor assembly of claim 1 with thetapered pins movable within the tapered channel to a wedging positionwherein substantially the entire length of each tapered pin contacts thesuture.
 8. The surgical anchor assembly of claim 1 comprising twotapered pins contained entirely within the tapered channel and with atleast one pin having a conically tapering outer surface.
 9. The surgicalanchor assembly of claim 1 with the tapered channel fixed in placerelative to the second anchor.
 10. The surgical anchor assembly of claim1 with the tapered pins comprising the only movable part on the proximalcollar.
 11. The surgical anchor assembly of claim 1 with relativemovement of the second anchor in a first direction relative to thesuture causing one or more of the tapered pins to wedge the sutureagainst the tapered channel.
 12. A surgical anchor assembly comprising:a first anchor; a suture attached to the first anchor; a second anchorhaving a distal collar attached to a proximal collar, with the proximalcollar having one or more tapered pins in a tapered channel, and withthe suture extending through the tapered channel, and with the pinsmovable axially and radially in the tapered channel to allow substantialrelative movement of the anchor body on the flexible element in only onedirection.
 13. The surgical anchor assembly of claim 12 with pins notattached to the proximal collar of the second anchor.
 14. The surgicalanchor assembly of claim 12 with the tapered pins contained entirelywithin the tapered channel.
 15. The surgical anchor assembly of claim 12with one or more of the pins having an outer surface with a shapecomplementary to an inner surface of the tapered channel.
 16. Thesurgical anchor assembly of claim 12 wherein the pins are configured tofriction lock against the suture when the second anchor is moved in afirst direction relative to the suture, and with the orientation of thepins remaining substantially unchanged.
 17. The surgical anchor assemblyof claim 12 wherein one or more of the pins has a half-cone shape. 18.The surgical anchor assembly of claim 12 with the tapered channel havinga fixed shape.
 19. A method for securing tissue during surgery,comprising: forming a tissue fold; piercing through the tissue fold witha delivery device; ejecting a first anchor from a delivery device at afirst side of the tissue fold; withdrawing the delivery device from thetissue fold; ejecting a second anchor from the delivery device at asecond side of the tissue fold; and preventing the second anchor frommoving away from the tissue fold by wedging one or more pins within atapered channel in the second anchor against a suture leading throughthe second anchor and attached to the first anchor, and, with thetapered channel having a fixed shape.
 20. The method of claim 15 withthe first and second anchors expanding from a compact configuration toan expanded configuration after the anchor is ejected from the deliverydevice.